The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is
to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate
(FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or
fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor
(PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically
suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment
option to patients who wish to simplify dosing by reducing pill burden or to improve the
tolerability of their treatment.

Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which
participants will switch treatment regimens at the start of the study, and the Stay on
Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their
baseline regimen during the first 24 weeks of the study (designed to provide an initial
active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit.

After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF
STR per protocol before switching to a commercially available source.

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)
[ Time Frame: Week 48 ]The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.
By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.

Change From Baseline in CD4 Count Through Week 48
[ Time Frame: Baseline to Week 48 ]The mean (SD) change in CD4 count was analyzed from baseline through Week 48.
By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.

Change From Baseline in Fasting Total Cholesterol Through Week 24
[ Time Frame: Baseline to Week 24 ]The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 24 was analyzed.

Change From Baseline in Fasting Total Cholesterol Through Week 48
[ Time Frame: Baseline to Week 48 ]The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 48 was analyzed.
By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.

Change From Baseline in Fasting HDL Cholesterol Through Week 48
[ Time Frame: Baseline to Week 48 ]The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 48 was analyzed.
By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.

Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48
[ Time Frame: Baseline to Week 48 ]The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 48 was analyzed.
By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.

Change From Baseline in Fasting Triglycerides Through Week 24
[ Time Frame: Baseline to Week 24 ]The mean (SD) change from baseline in fasting triglycerides through Week 24 was analyzed.

Change From Baseline in Fasting Triglycerides Through Week 48
[ Time Frame: Baseline to Week 48 ]The mean (SD) change from baseline in fasting triglycerides through Week 48 was analyzed.
By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.

Enrollment:

482

Study Start Date:

November 2010

Study Completion Date:

October 2014

Primary Completion Date:

January 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

Experimental:FTC/RPV/TDFParticipants will switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.

Experimental:SBR/Delayed SwitchParticipants will stay on baseline regimen (SBR; their existing treatment regimen of PI+RTV plus 2 NRTIs) at the beginning of the study through Week 24, and may switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.

On their first or second antiretroviral drug regimen; if on their second regimen,
HIV-1 RNA ≤ 50 copies/mL required at the time of the first change in antiretroviral
drugs, and no HIV RNA > 50 copies/mL measured at two consecutive time points after
first achieving HIV RNA < 50 copies/mL

No previous use of any approved or experimental nonnucleoside reverse transcriptase
inhibitor (NNRTI) drug for any length of time

Have a genotype prior to starting initial antiretroviral therapy and no known
resistance to any of the study agents

Males and females of childbearing potential must agree to utilize highly effective
contraception methods (two separate forms of contraception, one of which must have
been an effective barrier method, or been nonheterosexually active, practice sexual
abstinence, or have a vasectomized partner) from screening throughout the duration of
the study period and for 30 days following the last dose of study drug.

Anticipated need to initiate contraindicated drugs during the study, including drugs
not to be used with FTC, TDF, RPV; or subjects with known allergies to the excipients
of FTC/RPV/TDF STR tablets or Truvada® tablets

All investigational drugs

Medications and use of herbal/natural supplements excluded or to be used with caution
while participating in the study, including those not to be taken with Viread®,
Emtriva®, Truvada, and Rilpivirine.

Participation in any other clinical trial without prior approval from the sponsor was
prohibited while participating in this trial

Treatment with immunosuppressant therapies or chemotherapeutic agents within 3 months
of study screening, or expected to receive these agents or systemic steroids during
the study

History of liver disease, including Gilbert's Disease

Any other clinical condition or prior therapy making the subject unsuitable for the

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252940